Alkermes Phase III study spell good news for major depressive disorder space, says analyst

Positive top-line results were announced last month by Ireland-headquartered Alkermes (Nasdaq: ALKS) for its Phase III study of ALKS-5461 as an adjunctive therapy for major depressive disorder (MDD), says analyst.

As explored in research and consulting firm GlobalData’s  most recent MDD report, ALKS-5461 is one of six late-stage pipeline products showing promise with regards to improving efficacy and safety in the treatment of patients with the disorder. In October 2013, ALKS-5461 was granted fast track designation by the Food and Drug Administration for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.

Christos Michaelides, GlobalData's analyst covering neurology and ophthalmology, explains: “This status will both facilitate and expedite the FDA developmental and regulatory review process for ALKS-5461, which GlobalData anticipates will enter the US market in early 2018”.